510(k) · Cleared
Recalled · 2010Portable Intensive Care Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Research Laboratories, Inc. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cleared on Mar 2, 1998 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.
- Decided
- Mar 2, 1998
- Review
- 130 days
- Class
- Class II
- Product code
- DRO
- Recalls
- 3
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2010 | Not classified | Z-0937-2011 | Other | Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to… |
| Nov 15, 2006 | Not classified | Z-0343-2007 | Other | Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to… |
| Jun 30, 2006 | Not classified | Z-1195-06 | Other | The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DRO devicesDRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRO
FDA has decided no DRO device since 2007.
Median 510(k) review, days · DRO
Too few DRO 510(k)s in any year since 2007 to give a median.
Recalls per year · DRO
12in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DRO
2in 2025
MAUDE reports naming product code DRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 4 (4) | 2 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 12 | 19 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a…
Read the full statement (620 words)
The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and ‘children (described below), and will consist of patients both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below:
DEFIBRILLATOR FUNCTION:
The defibrillator function of the PIC is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. Patients may range from neo-natal to adult.
DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION:
With internal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to adult.
ECG MONITOR FUNCTION:
The ECG monitor function of the PIC is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult.
EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION:
The external transcutaneous pacing function of the PIC is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult.
NON-INVASIVE BLOOD PRESSURE FUNCTION:
The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult.
TEMPERATURE MONITOR FUNCTION:
The temperature monitor function of the PIC is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult.
PULSE OXIMETER FUNCTION:
The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult.
RESPIRATION RATE MONITOR FUNCTION:
The respiration rate monitor function of the PIC is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974034: Portable Intensive Care Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974034
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026